FDA Issues ICH Final Guidance for Continuous Manufacturing (CM) and Artificial Intelligence (AI) in Drug Manufacturing

The FDA is seeking public comments on the use of artificial intelligence (AI) in pharmaceutical manufacturing. As the use of AI continues to grow across industries, drug manufacturers are also looking to adopt AI-based technologies to improve drug discovery, formulation, process development, and quality control.

According to a recent article on Endpoints News, the FDA had released a draft guidance document titled “Artificial Intelligence in Drug Manufacturing” to help drug manufacturers and developers understand the potential of AI and how to use it safely and effectively in drug manufacturing. The guidance document discusses the benefits of using AI in various stages of drug manufacturing, as well as regulatory considerations for AI-based manufacturing processes, including data integrity, validation, and ongoing monitoring.

Today, the FDA announced in a Linkedin post that they have now released their final guidance:

“This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.”

The FDA’s call for comments on the use of AI in drug manufacturing is part of its efforts to keep up with the rapid pace of technological advancements in the industry. The agency aims to ensure that the adoption of AI-based technologies in drug manufacturing is done in a safe and effective manner.

You can download the stakeholder comment paper, “Discussion Paper: Artificial Intelligence in Drug Manufacturing” HERE.

Drug manufacturers and other stakeholders are encouraged to submit comments to the FDA to share their thoughts on the use of AI in pharmaceutical manufacturing. The FDA is particularly interested in hearing about the potential benefits and risks associated with AI-based technologies, as well as any regulatory challenges that may arise from their use.

The FDA encourages stakeholders to provide comments to the docket (FDA-2023-N-0487) by May 1, 2023.

Overall, the FDA’s efforts to gather public input on the use of AI in drug manufacturing demonstrate its commitment to promoting innovation and ensuring the safety and effectiveness of new technologies in the pharmaceutical industry. By working closely with stakeholders, the FDA can help pave the way for the responsible adoption of AI-based technologies in drug manufacturing and other areas of healthcare.